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The project will investigate the use of a novel technique, transcranial direct current stimulation (tDCS) in the treatment of patients with schizophrenia and patients with depression. tDCS involves the application of an extremely weak continuous electrical current to the brain through the placement of anode and a cathode on the scalp. The electrical current is generally completely imperceptible after initial period of tingling which takes about 30 seconds. Stimulation under the anode appears to increase brain activity where as stimulation under the cathode has the opposite effect. This research plan involves two clinical trials:

A study using tDCS to treat both the positive and negative symptoms of schizophrenia. The negative symptoms of schizophrenia such as lack of motivation and energy appear to arise due to a lack of activity in frontal brain areas. Positive symptoms such as hallucinations and confused thoughts may arise through over activity of brain areas more on the side and towards the back of the brain called the temporal cortex. We plan to apply tDCS such that it can simultaneously increased activity in these frontal brain areas and reduce activity over temporal cortex. We will compare active stimulation to a placebo condition which involves turning the stimulator off after 30 seconds. The capacity to target multiple symptom clusters is unique with this type of brain stimulation.

The study using tDCS in treatment resistant depression builds on a work with transcranial magnetic stimulation (TMS). TMS techniques in depression seem to work which increased left frontal brain activity or decrease right frontal brain activity. tDCS will be used to do the same thing with the anode used to increase left-sided brain activity and the cathode used to simultaneously decreased right-sided brain activity.

tDCS is potentially a better tolerated procedure than TMS and does not appear to have the same risk of seizure induction. Importantly, the equipment is quite inexpensive and this may prove to be an extremely safe and effective low-cost treatment for psychiatric disorders in Third World countries.

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Ages Eligible for Study:

18 Years to 75 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Schizophrenia

Participants will be included if they:

Are voluntary and competent to consent;

Have a diagnosis of Schizophrenia or Schizoaffective Disorder as confirmed by the Structure Clinical Interview for the DSM-IV (SCID-IV)

Have persistent positive and negative symptoms despite having trialled, or being currently medicated, with antipsychotic medication; and

are between the ages of 18 and 65.

Concomitant medications including:

Benzodiazepines,

Mood stabilizers (lithium, valproic acid)

Antidepressants (including serotonin reuptake inhibitors and tricyclic antidepressants) and anticholinergics will be allowed. Since carbamazepine has been shown to interfere with the effects of anodal tDCS, potential participants taking it will not be suitable for inclusion in the trial.

Depression

Participants will be included if they:

Are competent to consent;

Have a diagnosis of Major Depression and are currently experiencing a Major Depressive Episode as confirmed by the Structure Clinical Interview for the DSM-IV (SCID-IV);

Are treatment resistant, defined as a failure to achieve a clinical response, or an inability to tolerate, an antidepressant trial of sufficient dose for at least 6 weeks; and

Are between the ages of 18 and 75.

Concomitant medications including:

Benzodiazepines,

Mood stabilizers (lithium, valproic acid)

Antidepressants (including serotonin reuptake inhibitors and tricyclic antidepressants) and anticholinergics will be allowed. Since carbamazepine has been shown to interfere with the effects of anodal tDCS, potential participants taking it will not be suitable for inclusion in the trial.

Exclusion Criteria:

Patients will be excluded if they:

Have a DSM-IV history of substance abuse or dependence in the last 6 months;

Have a concomitant major and unstable medical or neurologic illness;

Are currently taking carbamazepine; or,

Are pregnant.

Patients will be withdrawn from the study if they:

Withdraw consent;

Experience significant clinical deterioration;

Fail to tolerate the procedure; or,

Develop a serious adverse event. In the event that a patient is withdrawn or drops out of the study, efforts will be made to obtain a final set of clinical, cognitive and neurophysiological measures at the time of withdrawal for a last observation carried forward analysis.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481026